MTVA

All Active Patients Successfully Reached Highest Planned Dose Levels of 48 mg and 64 mg in Ongoing Phase 1 Part 3 Study of DA-1726 16-Week Topline Data Expected in the Fourth Quarter of 2026 CAMBRIDGE, Mass., Aug. 6, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate strategic update. "During the second quarter of 2026, and subsequently, we continued to execute across both of our clinical development programs while further strengthening the differentiated profile of DA-1726 as a dual GLP-1/glucagon receptor agonist," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "Most recently, all active patients in both cohorts of our ongoing Phase 1 Part 3 study successfully reached the highest planned dose levels of 48 mg and 64 mg, representing an important execution milestone as we prepare for our 16-week topline data readout, expected in the fourth quarter of 2026. Also of note, during the quarter, we presented additional data from our 48 mg Phase 1 study of DA-1726 at both the EASL and ADA scientific conferences, which demonstrated up to 9.1% mean weight loss after just eight weeks of treatment, meaningful reductions in waist circumference and encouraging liver-related findings, reinforcing our confidence in DA-1726's potential best-in-class profile and its ability to address multiple aspects of cardiometabolic disease. Based on the continued trajectory of weight loss through eight weeks without evidence of plateau on the 48 mg dosage, we believe the ongoing 16-week study evaluating the 48 mg and higher 64 mg dosages has the potential to provide a more complete assessment of the drug's effects on weight loss, waist circumference, cardiometabolic health and liver-related outcomes." "In parallel, we continued to broaden the potential clinical utility of vanoglipel (DA-1241). During the quarter, we presented preclinical combination data at the ADA 2026 Scientific Sessions, demonstrating synergistic effects with both resmetirom in MASH and metformin in type 2 diabetes, while a peer-reviewed publication further highlighted the anti-fibrotic potential of GPR119 agonism. Together, these findings reinforce our strategy of advancing vanoglipel as a differentiated combination backbone for metabolic and liver diseases, designed to complement established and emerging therapies across cardiometabolic disorders." Second Quarter 2026 and Subsequent Highlights July 2026: Announced the completion of dose titration in the 16-week, Phase 1 Part 3 study of DA-1726, with all active patients successfully reaching the highest planned dose levels of 48 mg and 64 mg. June 2026: Presented new late-breaking data at the ADA 2026 Scientific Sessions supporting DA-1726's differentiated obesity profile and demonstrating the combination potential of vanoglipel with resmetirom in MASH and metformin in type 2 diabetes. May 2026: Presented additional data from the 48 mg Phase 1 trial of DA-1726 at EASL Congress 2026, demonstrating up to 9.1% mean body weight reduction without evidence of plateau and exploratory improvements in liver-related biomarkers, supporting the potential of DA-1726 in obesity and MASH. May 2026: Announced the publication of peer-reviewed preclinical research in Biomolecules & Therapeutics, supporting the anti-fibrotic potential of vanoglipel and the differentiated role of GPR119 agonism in MASH. April 2026: Dosed the first patient in Part 3 of the 16-week Phase 1 clinical trial evaluating DA-1726 in obese, otherwise healthy adults using one-step titration to 48 mg and two-step titration to 64 mg to safely achieve higher target doses and optimize tolerability. Anticipated Clinical Milestones DA-1726 in Obesity: Vanoglipel (DA-1241) in MASH: Second Quarter Financial and Operating Results Research and Development (R&D) Expenses were approximately $3.5 million for the second quarter ended June 30, 2026, as compared to approximately $2.3 million for the second quarter ended June 30, 2025. The increase of approximately $1.2 million was primarily attributable to higher direct R&D expenses related to DA-1726 product development. R&D expenses were approximately $5.6 million for the six months ended June 30, 2026, as compared to approximately $4.6 million for the six months ended June 30, 2025. The approximately $0.9 million increase was primarily attributable to $1.2 million in higher direct R&D expenses related to DA-1726 product development, partially offset by (i) $0.2 million in lower direct R&D expenses related to vanoglipel product development and (ii) $0.1 million in lower indirect employee compensation and benefits costs. General and Administrative (G&A) Expenses were approximately $1.9 million for the second quarter ended June 30, 2026, as compared to approximately $2.0 million for the second quarter ended June 30, 2025. The approximately $0.1 million decrease was primarily attributable to lower legal and professional fees.G&A expenses were approximately $3.8 million for the six months ended June 30, 2026, as compared to approximately $3.5 million for the six months ended June 30, 2025. The approximately $0.3 million increase was primarily attributable to (i) $0.1 million in higher consulting expenditures, (ii) approximately $0.1 million in higher employee compensation and benefits costs, and (iii) $0.1 million in higher other G&A expenses, which was primarily related to higher franchise tax expenses. Total Operating Expenses were approximately $5.4 million for the second quarter ended June 30, 2026, compared to approximately $4.3 million for the second quarter ended June 30, 2025. The approximately $1.1 million increase was primarily attributable to higher R&D expenses and was partially offset by lower G&A expenses. Total operating expenses were approximately $9.4 million for the six months ended June 30, 2026, compared to approximately $8.2 million for the six months ended June 30, 2025. The approximately $1.2 million increase was primarily attributable to higher R&D and G&A expenses for the six months ended June 30, 2026. Total Other Income was approximately $0.1 million for the three months ended June 30, 2026, as compared to approximately $0.3 million for the three months ended June 30, 2025. The approximately $0.2 million decrease was primarily attributable to an approximately $0.2 million negative impact from the change in fair value of warrant liabilities due to the impact of its common stock's decline in stock price and approximately $0.1 million in lower interest income, net, due to lower balances of cash and cash equivalents and lower interest rates. Total other income was approximately $0.3 million for the six months ended June 30, 2026, as compared to approximately $0.5 million for the six months ended June 30, 2025. The approximately $0.2 million decrease was primarily attributable to (i) $0.1 million in lower gain from change in fair value of warrant liabilities due to the impact of the Company's common stock's decline in stock price and (ii) $0.1 million in lower interest income, net, due to lower balances of cash and cash equivalents and lower interest rates. Net Loss was $5.3 million, or $0.90 per basic and diluted share, for the second quarter ended June 30, 2026 based on 5,931,875 weighted average shares of common stock outstanding, compared with a net loss of $4.0 million, or $2.87 per basic and diluted share, based on 1,389,753 weighted average shares of common stock outstanding for the second quarter ended June 30, 2025. Net loss for the six months ended June 30, 2026, was approximately $9.1 million, or $1.69 per basic and diluted share, based on 5,398,683 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately $7.7 million, or $6.59 per basic and diluted share, based on 1,162,692 weighted average shares of common stock, basic and diluted, for the six months ended June 30, 2025. Cash and cash equivalents was $12.6 million as of June 30, 2026, compared with $10.3 million as of December 31, 2025. The company expects its cash position will be adequate to fund operations through 2026. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP-1 receptor agonists such as semaglutide. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a potential first-in-class drug candidate targeting G-protein-coupled receptor 119 (GPR119). In preclinical studies, vanoglipel demonstrated a positive metabolic effect on glucose and lipid control, and also proved differentiated hepatic benefits reducing hepatic steatosis, hepatic inflammation, and liver fibrosis independent of metabolic improvement. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of preclinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] - Tables to Follow - View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-second-quarter-2026-financial-results-and-provides-corporate-update-302845253.html

48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of Plateau Exploratory FibroScan Assessments Demonstrated Early Liver-Related Improvements Ongoing Phase 1 Part 3a/3b Titration Studies Continue to Evaluate Extended Treatment at Higher-Dose Levels CAMBRIDGE, Mass., May 27, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the presentation of new Phase 1 data on DA-1726, a novel dual oxyntomodulin (OXM) analog agonist targeting glucagon-like peptide-1 receptors (GLP1R) and glucagon receptors (GCGR), in a late-breaking poster presentation at the European Association for the Study of the Liver Congress 2026 (EASL 2026), being held May 27–30 in Barcelona, Spain. The data highlighted favorable safety and tolerability, clinically meaningful reductions in body weight and waist circumference at the 48 mg dose without titration, and exploratory, noninvasive liver-related findings supporting continued evaluation in metabolic dysfunction-associated steatohepatitis (MASH). "These late-breaking Phase 1 findings presented at EASL 2026 continue to reinforce DA-1726's differentiated metabolic profile as a dual GLP-1 and glucagon receptor agonist with meaningful effects on both body weight, waist circumference and liver-related parameters," said Hyung Heon Kim, Chief Executive Officer of MetaVia. "Importantly, DA-1726 demonstrated robust and progressive weight loss up to 9.1% at the 48 mg dose level without evidence of plateau, while maintaining favorable tolerability even in the absence of dose titration. We are also encouraged by the exploratory FibroScan findings, which demonstrated early and consistent improvements across multiple noninvasive liver biomarkers, including liver stiffness, CAP and FAST scores. These findings further illustrate the potential of DA-1726 in obesity and MASH, where metabolic and hepatic dysfunction are closely linked. Based on these findings, we continue to advance the ongoing Phase 1 Part 3a/3b titration studies designed to evaluate longer-term dosing strategies, optimize tolerability at higher exposures, and further assess durability of metabolic and liver-related effects." The late-breaking poster presentation reported results from the 48 mg cohort of the randomized, double-blind, placebo-controlled Phase 1 multiple ascending dose (MAD) study evaluating DA-1726 in obese but otherwise healthy adults. Subjects received once-weekly subcutaneous DA-1726 or placebo for four weeks without titration in a 2:1 randomization ratio. Of the nine subjects enrolled in the 48 mg cohort, six entered an optional four-week extension phase at the same dose. DA-1726 was generally well tolerated up to the 48 mg dose level, with no serious adverse events or treatment-related discontinuations observed. Gastrointestinal adverse events were primarily mild-to-moderate and transient in nature, even without dose titration. In addition, despite glucagon receptor activation, no clinically meaningful changes in cardiovascular parameters, including heart rate and QTcF, were observed. Clinically meaningful reductions in body weight and waist circumference were observed in the 48 mg cohort. Participants achieved a mean body-weight reduction of 6.1% at Day 26 and 9.1% at Day 54 (p < 0.05 vs placebo at Day 26), with no evidence of a plateau through Week 8. Waist circumference was reduced by 5.8 cm at Day 26 and 9.8 cm at Day 54 (p < 0.05 vs placebo at Day 26). Exploratory noninvasive liver assessments using FibroScan also suggested liver-related improvements at Day 54, including a reduction in controlled attenuation parameter (CAP) of −20.0 dB/m in the 48 mg group compared with +24.0 dB/m with placebo. Improvements in liver stiffness were also observed, with a −10.3% change from baseline by vibration-controlled transient elastography (VCTE) versus +13.8% with placebo. In addition, directional improvements from baseline were observed in FibroScan-aspartate aminotransferase (FAST) score, supporting further long-term evaluation of DA-1726 in obesity-associated liver disease and MASH. Presentation Details: Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue, in a Higher-Dose Phase 1 Cohort with Exploratory Noninvasive Liver Assessment Presenting Author: Chris Fang, Chief Medical Officer, MetaVia Abstract Number: LB26-5204 Final Abstract ID: LBP-010 Session: Late Breaking Posters Presentation Date: Wednesday, May 27, 2026 Presentation Start: 8:30 am CET A copy of the poster will be available on the Posters section of the MetaVia website after the presentation. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®), a leading GLP-1 receptor agonist. Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists such as semaglutide. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-presents-higher-dose-phase-1-results-for-da-1726-at-easl-congress-2026-supporting-potential-in-obesity-and-mash-302782740.html

48 mg Phase 1 Data Demonstrated Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit Key Milestone Achieved with Dosing of the First Patient in Phase 1 Part 3 16-Week Titration Study Evaluating 48 mg (1-Step) and 64 mg (2-Step) Regimens; Data Expected in Fourth Quarter 2026 CAMBRIDGE, Mass., May 14, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate strategic update. "We continued to build strong momentum in the first quarter of 2026 and most recently, as highlighted by the on-time dosing of the first patient in Part 3 of our Phase 1 clinical trial of DA-1726 for obesity, which followed closely on the heels of receiving IRB approval," said Hyung Heon Kim, Chief Executive Officer of MetaVia. "In this part of the trial, we are evaluating higher doses through optimized titration regimens, including a one-step escalation to 48 mg and a two-step escalation to 64 mg. This strategy is intended to safely reach higher therapeutic doses with improved tolerability, which could represent a meaningful advantage compared to currently marketed therapies that require longer, more gradual titration. Our January financing provides the capital to support the execution of this study, and we look forward to reporting data from Part 3 in the fourth quarter of 2026." "This trial is designed to build on the compelling results reported in January from the 8-week, non-titrated 48 mg cohort, which demonstrated robust early weight loss of 9.1%, statistically significant reductions in waist circumference, meaningful improvements in glucose control and direct liver benefit, all with a favorable safety and tolerability profile. Based on these results, we believe DA-1726 has the potential to establish a best-in-class profile in obesity and broader cardiometabolic disease, driven by its differentiated dual GLP-1/glucagon mechanism. We also look forward to presenting additional data from the Phase 1 48 mg dose cohort on the direct liver benefit of DA-1726 at the European Association for the Study of the Liver (EASL) Congress 2026." First Quarter 2026 and Subsequent Highlights May 2026: Announced the presentation of additional data from the 48 mg Phase 1 trial of DA-1726 at the EASL Congress 2026 in a poster entitled, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DA-1726, an Oxyntomodulin Analogue, in a Higher-Dose Phase 1 Cohort with Exploratory Noninvasive Liver Assessment. April 2026: Dosed the first patient in Part 3 of the Phase 1 clinical trial evaluating DA-1726 in obese, otherwise healthy adults, consisting of two 16-week titration cohorts designed to evaluate one-step dose titration to 48 mg and two-step dose titration to 64 mg, designed to safely achieve higher target doses and further optimize tolerability. March 2026: Received IRB approval from Clinical Pharmacology of Miami for the Phase 1 Part 3 16-week titration study of DA-1726. March 2026: Announced a comprehensive global intellectual property portfolio supporting vanoglipel with 48 granted and pending patents across three patent families in the U.S., Europe, Japan, China and other countries, providing protection into 2035, unless extended further. Exclusively licensed from Dong-A ST Co., Ltd., the patent portfolio provides broad protection for vanoglipel itself, how it is manufactured, and its potential use across a range of serious metabolic and liver conditions. February 2026: Strengthened global intellectual property position for DA-1726 with 39 granted and pending patents in the U.S. and internationally, providing protection through at least 2041, unless extended further. Exclusively licensed from Dong-A ST Co., Ltd., the portfolio broadly covers DA-1726's novel peptide structure, its long-acting dual-incretin design, and therapeutic use across obesity, metabolic disease, and related cardiometabolic conditions. February 2026: Announced positive AI-modeling results from the ongoing collaboration with Syntekabio, Inc., an AI-driven drug discovery company, leveraging their proprietary DeepMatcherﾮ platform. The results confirmed vanoglipel's strong inflammatory and cardiometabolic target engagement, supporting development in MASH and, potentially, type 2 diabetes. January 2026: Closed an underwritten public offering of shares of common stock, pre-funded warrants, Series C Common Warrants and Series D Common Warrants for gross proceeds of approximately $9.3 million, prior to deducting underwriting discounts and commissions and offering expenses and excluding any potential future proceeds from the exercise of warrants. January 2026: Announced positive, statistically significant results from the 8-week (extended from four weeks) non-titrated 48 mg MAD cohort of the Phase 1 clinical trial of DA-1726. The results showed robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, alongside a favorable safety and tolerability profile. Anticipated Clinical Milestones DA-1726 in Obesity: Data readout from Phase 1 Part 3, 16-week titration studies, evaluating titration to 48 mg in one step and 64 mg via a two-step regimen, is expected in the fourth quarter of 2026. Vanoglipel (DA-1241) in MASH: The Company is currently working to schedule an end-of-Phase 2 meeting with the FDA. First Quarter Financial and Operating Results Research and Development (R&D) Expenses were approximately $2.1 million for the first quarter ended March 31, 2026, as compared to approximately $2.3 million for the first quarter ended March 31, 2025. The decrease of approximately $0.2 million was primarily attributable to (i) $0.1 million in lower direct R&D expenses related to vanoglipel product development and (ii) $0.1 million in lower indirect employee compensation and benefits costs. Included in direct R&D costs were expenses totaling $0.7 million and $1.1 million for the three months ended March 31, 2026 and 2025, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party). General and Administrative (G&A) Expenses were approximately $1.9 million for the first quarter ended March 31, 2026, as compared to approximately $1.6 million for the first quarter ended March 31, 2025. The approximately $0.3 million increase was primarily attributable to (i) approximately $0.1 million in higher consulting expenditures, (ii) approximately $0.1 million in higher franchise tax expenses, and (iii) $0.1 million in higher legal and professional fees. Total Operating Expenses were approximately $4.0 million for the first quarter ended March 31, 2026, compared to approximately $3.9 million for the first quarter ended March 31, 2025. The approximately $0.1 million increase was primarily attributable to higher G&A expenses and was partially offset by lower R&D expenses. Total Other Income was approximately $0.2 million for the first quarter ended March 31, 2026, consistent with the corresponding period in 2025. Net Loss was $3.8 million, or $0.79 per basic and diluted share, for the first quarter ended March 31, 2026 based on 4,859,567 weighted average shares of common stock outstanding, compared with a net loss of $3.7 million, or $3.93 per basic and diluted share, based on 933,109 weighted average shares of common stock outstanding for the first quarter ended March 31, 2025. Cash and cash equivalents was $13.7 million as of March 31, 2026, compared with $10.2 million as of December 31, 2025. The company expects its cash position will be adequate to fund operations into the fourth quarter of 2026. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] - Tables to Follow - View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-first-quarter-2026-financial-results-and-provides-corporate-update-302772529.html

48 mg Phase 1 Data Demonstrate Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit Planned Phase 1 Part 3 16-Week Titration Study to Evaluate 48 mg (1-Step) and 64 mg (2-Step) Regimen Receives IRB Approval; Initiation Expected in April of 2026 with Data Anticipated in the Fourth Quarter $10.3 Million in Cash and Cash Equivalents at End of Year and Proceeds From January 2026 Public Offering is Expected to Fund the Company Into the Fourth Quarter of 2026 CAMBRIDGE, Mass., March 26, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the year ended December 31, 2025, and provided a corporate strategic update. "We made significant progress advancing our cardiometabolic portfolio during the year, punctuated by the positive data, released in January of this year, from the Phase 1 extended 8-week, non-titrated 48 mg cohort of lead asset DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity and related metabolic disorders," stated Hyung Heon Kim, Chief Executive Officer of MetaVia. "These results demonstrated robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, all achieved without titration and with a favorable safety and tolerability profile. We believe this combination of weight loss, glycemic control, direct hepatic benefit and tolerability meaningfully differentiates DA-1726 and supports its potential to deliver a best-in-class profile in obesity and broader cardiometabolic disease. Importantly, DA-1726 is supported by a growing intellectual property estate comprising 39 granted and pending patents in the United States and internationally, providing protection at least through 2041." "On the heels of the positive Phase 1 data, we strengthened our balance sheet in January with gross proceeds of $9.3 million from an underwritten public offering, providing additional capital to advance the DA-1726 program. Having recently received Institutional Review Board (IRB) approval from the Clinical Pharmacology of Miami, we expect to initiate dosing in our Phase 1 Part 3, 16-week titration studies evaluating escalation to 48 mg in a single step and 64 mg using a two-step regimen in April, with data anticipated in the fourth quarter of 2026." Mr. Kim continued, "Beyond DA-1726, we continued to advance vanoglipel (DA-1241), a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, with the presentation of positive Phase 2a data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meetingﾮ 2025, highlighting clinically meaningful improvements in glucose control, liver health and plasma lipidomic profiles over 16 weeks. In parallel, results from our collaboration with Syntekabio using the DeepMatcherﾮ artificial intelligence (AI) platform confirmed strong inflammatory and cardiometabolic target engagement, further supporting development of vanoglipel in MASH and, potentially, in type 2 diabetes. We believe both programs position MetaVia at the forefront of next-generation cardiometabolic innovation as we move into 2026." Fourth Quarter 2025 and Subsequent Highlights March 2026: Received IRB approval from Clinical Pharmacology of Miami for the Phase 1 Part 3 16-week titration study of DA-1726, enabling higher-dose evaluation in obese, otherwise healthy adults. March 2026: Announced a comprehensive global intellectual property portfolio supporting vanoglipel with 48 granted and pending patents across three patent families in the U.S., Europe, Japan, China and other countries, providing protection into 2035, unless extended further. Exclusively licensed from Dong-A ST Co., Ltd., the patent portfolio provides broad protection for vanoglipel itself, how it is manufactured, and its potential use across a range of serious metabolic and liver conditions. February 2026: Strengthened global intellectual property position for DA-1726 with 39 granted and pending patents in the U.S. and internationally, providing protection through at least 2041, unless extended further. Exclusively licensed from Dong-A ST Co., Ltd., the portfolio broadly covers DA-1726's novel peptide structure, its long-acting dual-incretin design, and therapeutic use across obesity, metabolic disease, and related cardiometabolic conditions. February 2026: Announced positive AI-modeling results from the ongoing collaboration with Syntekabio, Inc., an AI-driven drug discovery company, leveraging their proprietary DeepMatcherﾮ platform. The results confirmed vanoglipel's strong inflammatory and cardiometabolic target engagement, supporting development in MASH and, potentially, type 2 diabetes. January 2026: Closed an underwritten public offering of shares of common stock, pre-funded warrants, Series C Common Warrants and Series D Common Warrants for gross proceeds of approximately $9.3 million, prior to deducting underwriting discounts and commissions and offering expenses and excluding any potential future proceeds from the exercise of warrants. January 2026: Announced positive statistically significant results from the 8-week (extended from four weeks) non-titrated 48 mg MAD cohort of the Phase 1 clinical trial of DA-1726. The results showed robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, alongside a favorable safety and tolerability profile. November 2025: Presented positive new data from the Phase 2a clinical trial evaluating vanoglipel as a potential treatment for MASH in a poster presentation at the AASLD The Liver Meetingﾮ 2025. The data highlight vanoglipel's differentiated dual activity across both hepatic and metabolic pathways, demonstrating clinically meaningful improvements in glucose control, liver health, and plasma lipidomic profiles following 16 weeks of treatment. November 2025: Presented new Phase 1 and pre-clinical data on DA-1726 in two poster presentations at ObesityWeekﾮ 2025. The Phase 1 data demonstrated favorable safety and tolerability, a newly characterized pharmacokinetic (PK) profile supporting once-weekly dosing, and meaningful reductions in body weight and waist circumference following four weeks of treatment. Additionally, in a diet-induced obesity (DIO) mouse model, DA-1726 achieved comparable weight loss to pemvidutide with superior lipid-lowering efficacy. Anticipated Clinical Milestones DA-1726 in Obesity: Dosing of the first patient in the company's Phase 1 Part 3, 16-week titration studies, evaluating titration to 48 mg in one step and 64 mg via a two-step regimen, is expected in April of 2026. Data readout for these Phase 1 studies is expected in the fourth quarter of 2026. Vanoglipel (DA-1241) in MASH: The Company is currently working to schedule an end-of-Phase 2 meeting with the FDA. Fourth Quarter Financial and Operating Results Research and Development (R&D) Expenses were approximately $6.8 million for the year ended December 31, 2025, as compared to approximately $21.6 million for the year ended December 31, 2024. The decrease of approximately $14.8 million was primarily attributable to (i) $10.8 million in lower direct R&D expenses related to vanoglipel (DA-1241) product development, (ii) $3.9 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.2 million in lower direct other R&D costs. These decreases were partially offset by $0.1 million in higher indirect consulting expenses and a slight increase in indirect employee compensation and benefits. Included in direct R&D costs were expenses totaling $3.4 million and $4.9 million for 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party). General and Administrative (G&A) Expenses were approximately $6.9 million for the year ended December 31, 2025, as compared to approximately $7.3 million for the year ended December 31, 2024. The approximately $0.4 million decrease was primarily attributable to (i) $0.7 million in lower consulting expenditures, (ii) $0.1 million in lower insurance, and (iii) $0.2 million in lower other G&A expenses. These decreases were partially offset by $0.5 million in higher legal and professional fees and $0.1 million in higher employee compensation and benefits. Total Operating Expenses were approximately $13.7 million for the year ended December 31, 2025, compared to approximately $28.8 million for the year ended December 31, 2024. The approximately $15.1 million decrease was primarily attributable to lower R&D expenses and G&A expenses. Total Other Income was approximately $0.7 million for the year ended December 31, 2025, compared to approximately $1.2 million for the year ended December 31, 2024. The approximately $0.5 million decrease was primarily attributable to (i) $0.4 million in lower interest income, net, due to lower cash balances and lower interest rates, and (ii) $0.1 million in lower gain related to the change in fair value of warrant liabilities due to the impact of the Company's common stock's volatile stock price during the last few years. Net Loss was $13.0 million, or $7.35 per basic and diluted share, for the year ended December 31, 2025 based on 1,766,026 weighted average shares of common stock outstanding, compared with a net loss of $27.6 million, or $39.13 per basic and diluted share, based on 705,193 weighted average shares of common stock outstanding for the year ended December 31, 2024. Cash and cash equivalents was $10.3 million as of December 31, 2025, compared with $16.0 million as of December 31, 2024. With these funds and proceeds from the January 2026 public offering, the company expects its cash position will be adequate to fund operations into the fourth quarter of 2026. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's history of net losses, the sufficiency of its existing cash on hand to fund operations and raising additional capital; adverse global economic conditions; MetaVia's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws, regulations or Nasdaq listing rules; the effects of changes to MetaVia's stock price; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] - Tables to Follow - View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-year-end-2025-financial-results-and-provides-corporate-update-302725141.html

DeepMatcherﾮ Platform Confirms Strong Inflammatory and Cardiometabolic Target Engagement, Supporting Development in MASH and Potential Type 2 Diabetes CAMBRIDGE, Mass., Feb. 4, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today provided an update on its ongoing collaboration with Syntekabio, Inc., an artificial intelligence (AI)-driven drug discovery company, leveraging their proprietary DeepMatcherﾮ platform. Using AI-based compound-protein interaction modeling, Syntekabio has identified key disease targets for MetaVia's oral G-protein-coupled receptor 119 (GPR119) agonist, vanoglipel (DA-1241). The analysis highlighted inflammatory diseases, cardiometabolic disorders, and cancer as the top predicted target areas, directly aligning with MetaVia's therapeutic focus. Notably, cancer was identified, in part, due to the strong reduction in inflammation observed in AI-predicted target pathways. "The AI modeling results provide strong confirmation that vanoglipel engages key inflammatory targets, which supports our strategy in metabolic dysfunction-associated steatohepatitis (MASH) and potential type 2 diabetes (T2D)," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "Furthermore, the identification of inflammation, cardiometabolic, and cancer-related pathways reinforces that we are focused in the right therapeutic areas. MetaVia continues to advance DA-1241 for MASH and T2D, bolstered by our Phase 2a clinical study results which demonstrated direct hepatic activity, improvements in glucose metabolism, and a favorable safety and tolerability profile in 109 patients over 16 weeks. Together, these insights give us confidence in DA-1241's broader therapeutic potential." MetaVia will continue leveraging the Syntekabio AI platform to explore additional indications and further optimize the therapeutic profile of vanoglipel. About Vanoglipel (DA-1241) Vanoglipel (DA-1241) is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. Vanoglipel has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of vanoglipel has been demonstrated in multiple pre-clinical animal models of MASH and T2D where vanoglipel reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a, 1b and 2a trials, vanoglipel was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. About Syntekabio Syntekabio Co., Ltd. (KOSDAQ: 226330) is a drug discovery company bringing together biology and AI/ML since 2009 and facilitating the discovery of first-in-class and best-in-class compounds, rapidly. The company has its own supercomputer cloud, along with a global contract research organization network to complement and validate its computational results. Syntekabio offers clients a one-stop shop, with technologies and tailored services to rapidly generate and optimize drug candidates from target to IND-enabling. Syntekabio's disease-agnostic platform generates a continual stream of hits, leads, and drug candidates that are readily available for purchase. The company also undertakes client-specific projects to identify highly promising development candidates for specific targets and indications. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-announces-positive-ai-modeling-results-from-its-ongoing-syntekabio-collaboration-confirming-key-therapeutic-targets-for-vanoglipel-302677939.html

By David Bautz, PhD NASDAQ:MTVA READ THE FULL MTVA RESEARCH REPORT Business Update Positive Results for 8-week 48 mg Cohort in Phase 1b Trial of DA-1726 On January 5, 2026, MetaVia, Inc. (NASDAQ:MTVA) announced positive and statistically significant results from the 8-week 48 mg cohort from the Phase 1b trial of DA-1726, the company’s dual oxyntomodulin analog that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) agonist. The results showed a robust reduction in weight and waist circumference, along with large improvements in glucose control and reductions in liver stiffness. The drug also continued to be safe and well tolerated. The following figure on the left shows the weight loss seen thus far for the different cohorts from the Phase 1 study that were treated for four weeks. There is a clear dose response starting from the 8mg dose through the 48 mg dose. The figure on the right compares the 4-week data to the 8-week data for the 48 mg cohort. The following tables give the placebo adjusted results for body weight and waist circumference for the 48 mg cohort. One of the subjects in the placebo group reported implementing a “no carbohydrate” diet while participating in the study, which may have led to a substantial weight loss. Thus, the company performed a placebo adjusted analysis with and without that individual. For waist circumference, the placebo outlier did not have a substantial reduction in waist circumference, which further supports DA-1726’s direct effect on waist circumference. DA-1726 also showed positive effects on glucose control and liver health. Fasting glucose decreased from a mean baseline of 105.3 mg/dL to a mean of 93 mg/dL after eight weeks of treatment. Mean HbA1c was also controlled in this non-diabetic population, with a mean change of -0.22% after eight weeks of DA-1726 therapy. One pre-diabetic patient began the study with an HbA1c of 6% at baseline, and that was reduced to 5.5% after eight weeks of treatment. For liver health, the mean VCTE (FibroScan®) was 5.9 kPa at baseline, and that decreased to a mean 4.5 kPa after eight weeks of treatment with DA-1726. This is in contrast to placebo-treated patients that had a mean baseline VCTE of 5.1 kPa that increased to a mean 6 kPa after eight weeks. These results show that DA-1726 is having a positive effect on liver inflammation and stiffness. In regard to safety and tolerability, there was only one DA-1726-treated subject who discontinued from the study, which was due to being in the hospital as the result of a car accident while riding in a passenger seat. The following table gives an overview of the GI treatment emergent adverse events, which show an increase in mild to moderate events in the 48 mg cohort. However, there was no titration with that cohort, thus we believe the incidence of GI events will likely decrease in Part 3 of the trial when titration is introduced. The final stage of the Phase 1 trial will evaluate DA-1726 in two titration dosing regimens. The cohort in Part 3a will receive four weeks of 16 mg DA-1726 followed by twelve weeks of 48 mg DA-1726. The cohort in Part 3b will follow a two-step titration: subjects will receive 16 mg DA-1726 for four weeks, followed by 32 mg DA-1726 for four weeks, and then 64 mg DA-1726 for eight weeks. The company is attempting to mitigate the GI AE profile through titration to the target dose. Part 3 of the Phase 1 trial is expected to begin in the first quarter of 2026, and we anticipate topline results in the fourth quarter of 2026. DA-1726 Competitive Analysis At this point, we believe the most informative comparisons of DA-1726’s early data are with other weight loss drugs that also target the glucagon receptor. The following table provides efficacy and tolerability data for different glucagon receptor-targeting therapies and tirzepatide, which is a GLP-1R/GIPR co-agonist. While a direct comparison between the various compounds is not possible due to differences in titration, inclusion/exclusion criteria, and study length, this table is provided as a means to show potential trends in the data. In addition, the competitor compounds are further along in development than DA-1726, but their results give a good indication of the type of activity DA-1726 will need to show in longer term trials. Lastly, while AE rates for nausea, vomiting, and diarrhea are provided, investors should keep in mind that DA-1726 did not titrate up to 48 mg, while the competitor compounds’ results were obtained following titration to the target dose. Based upon the early data for DA-1726, we believe the drug could potentially match or even exceed the efficacy results for the other glucagon-targeted therapies in a long-term trial, and if the Phase 1b Part 3 titration results show decreased GI AEs (which is typical for this class of drugs that implement a titration strategy), DA-1726 could represent a fully differentiated asset with a best-in-class efficacy and tolerability profile. Financial Update On January 16, 2026, MetaVia announced the closing of a $9.3 million underwritten public offering that included the full exercise of the underwriter’s overallotment option to purchase additional shares and warrants. The company sold 3,005,574 shares of common stock, 4,508,361 Series C warrants, and 4,508,361 Series D warrants at a combined price of $3.10 per share of common stock and accompanying Series C and Series D warrants. The Series C and D warrants are both immediately exercisable and have an exercise price of $3.10; the Series C warrants expire in five years, while the Series D warrants expire in two years. The series D warrants are also callable by MetaVia following the release of a positive data readout for Part 3 of the Phase 1b trial of DA-1726. Lastly, both the Series C and D warrants are fixed price, and there is no variable pricing feature or alternative exercise provisions. If the full allotment of both the Series C and D warrants are exercised for cash, it would yield approximately $28 million in future gross proceeds. Conclusion The 48 mg 8-week data for DA-1726 provided additional evidence for the drug’s potential; weight loss continued to increase with no sign of plateauing, waist circumference decreases are showing signs of potential best-in-class efficacy, and the compound is seeming to have a positive effect on liver inflammation and stiffness. The AE profile showing increased incidences of GI effects should not alarm investors, as the company was essentially testing how high it could push the dosage without needing to titrate. We fully expect the GI AEs to decrease in Part 3 of the Phase 1 trial following implementation of a titration schedule. However, we don’t expect this to decrease the efficacy results. We look forward to the topline data from Part 3 of the Phase 1b trial in the fourth quarter of 2026. These results will mark the end of the Phase 1b trial and will be used to design Phase 2 trials. Following the company’s recent financing, our valuation is now $60 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. 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Statistically Significant (p=0.006) Waist Circumference Reduction of 9.8 cm at Day 54 Significant Direct Hepatic Activity with a 23.7% Reduction in Liver Stiffness (VCTE) by Day 54 Strong Glycemic Response with a 12.3 mg/dL Fasted Glucose Reduction by Day 54 Robust Weight Loss with 9.1% Reduction (21.2 lbs) by Day 54 CAMBRIDGE, Mass., Jan. 5, 2026 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive statistically significant results from the 8-week (extended from four weeks) non-titrated 48 mg, multiple ascending dose (MAD) cohort of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The results show robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, alongside a favorable safety and tolerability profile. In the non-titrated 48 mg cohort, patients experienced no treatment-related discontinuations, and gastrointestinal events were mild to moderate in severity. By Day 26, patients receiving DA-1726 achieved a statistically significant average weight reduction of 6.1% (14.6 lbs.) (p=0.003) and a statistically significant decrease in waist circumference of 5.8 cm (2.3 inches) (p=0.006). These improvements deepened through Day 54, with an average weight loss of 9.1% (21.2 lbs.) and a statistically significant 9.8 cm (3.8 inch) (p=0.022) reduction in waist circumference. Patients also demonstrated a 12.3 mg/dL improvement in fasted glucose from a baseline of 105.3 mg/dL by Day 54. In addition, vibration-controlled transient elastography (VCTE) indicated a 23.7% reduction in liver stiffness from a baseline of 5.9 kPa, suggesting a significant direct hepatic effect from DA-1726. "Extending DA-1726 administration to a full eight weeks at the non-titrated 48 mg dose has provided us with extremely encouraging insights," said Hyung Heon Kim, president and chief executive officer of MetaVia. "Patients in this cohort achieved a statistically significant 6.1% weight loss by Day 26 and 9.1% by Day 54, along with reductions in waist circumference of 5.8 cm and 9.8 cm at those same time points. We believe the statistically significant waist reductions reflect the glucagon component of DA-1726, which may contribute to deeper visceral fat loss than GLP-1 agonists alone. Combined with a favorable tolerability profile with no treatment-related discontinuations, these results highlight DA-1726's differentiated potential to be a best-in-class treatment option." "We also observed meaningful metabolic improvements, including a 12.3 mg/dL reduction in fasted glucose and early HbA1c benefits, such as a drop from 6.0% to 5.5% by day 54, in a prediabetic subject. These findings are especially important because the vast majority of people with obesity—ranging from 70% to 80%—have diabetes or prediabetes, and diabetic patients typically receive broader insurance coverage for anti-obesity therapies. DA-1726 has the potential to be the most effective GLP-1/glucagon dual agonist in development that has demonstrated glucose lowering without elevations, which may offer both clinical and reimbursement advantages. Because VCTE is the leading noninvasive tool for liver stiffness assessment and is recognized by the FDA as a biomarker in MASH development, seeing a 23.7% reduction in only eight weeks underscores the hepatic potential of DA-1726. Taken together, the data reinforce our view that DA-1726 has best-in-class potential, delivering a compelling balance of weight loss, metabolic improvement, direct hepatic benefit, and tolerability as we advance toward later-stage development." Mr. Kim added, "Looking ahead, our planned 16-week titration studies—to 48 mg in a single step and to 64 mg using a two-step regimen—reflect our confidence in DA-1726's tolerability and our expectation that it will compare favorably to the slower, more restrictive titration schedules required by today's GLP-1 drugs. We believe this represents a key competitive advantage. With results expected in the fourth quarter of 2026, we are well positioned to unlock further value creation as we continue advancing DA-1726 toward later-stage development." The Phase 1 trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese but otherwise healthy adults with a body mass index (BMI) of 30–45 kg/m². Nine subjects in each cohort were randomized in a 6:3 ratio, with each subject receiving either 4 weekly administrations of DA-1726 or placebo. The extended dosing cohort added 4 weekly administrations of DA-1726 or placebo for a total of 8 weeks of exposure. The primary objective was to assess safety and tolerability based on adverse events (AEs), serious adverse events (SAEs), treatment-emergent events (TAEs), and discontinuations. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others. For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220. About DA-1726 DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared to tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide. In the Phase 1 multiple ascending dose (MAD) trial in obesity, the 32 mg dose of DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist circumference reduction. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements, which include, among other statements, statements regarding the timing and release of data related to the company's planned 16-week titration studies. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's ability to execute on its commercial strategy; MetaVia's expectations regarding the sufficiency of its existing cash on hand to fund MetaVia's operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-positive-statistically-significant-results-from-its-phase-1b-clinical-trial-of-da-1726-in-metabolic-disease---demonstrating-strong-glycemic-response-significant-direct-hepatic-effects-robust-weight-loss-and-favor-302652206.html

Dosed the First Patient in the 8-Week 48 mg MAD Cohort of its Phase 1 Clinical Trial to Further Explore Non-Titrated Maximum Tolerated Dose of DA-1726 for the Treatment of Obesity; Top-Line Data Expected by Year-End 2025 $14.3 Million in Cash at End of Third Quarter is E xpected to Fund the Company Into 2026 CAMBRIDGE, Mass., Nov. 6, 2025 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate strategic update. "During the third quarter and subsequently, we continued to make strong progress advancing our next-generation cardiometabolic portfolio, highlighted by the Phase 1 data for DA-1726 presented just recently at ObesityWeek® 2025," stated Hyung Heon Kim, Chief Executive Officer of MetaVia. "These results further reinforce DA-1726's potential as a differentiated dual oxyntomodulin (OXM) analog agonist for the treatment of obesity. As previously reported, the 32 mg cohort demonstrated a strong safety and tolerability profile without the need for titration, along with potentially best-in-class weight loss and waist circumference reduction. Participants achieved up to a 6.3% mean body-weight reduction and decreases in waist circumference of up to 3.9 inches, with effects sustained for two weeks after dosing ended. Newly reported pharmacokinetic (PK) data showed linear, dose-proportional exposure and an approximately 80-hour half-life, supporting the feasibility of once-weekly dosing." "Based on these encouraging findings, during the quarter we extended the Phase 1 study to include an 8-week, 48 mg cohort to assess longer-term efficacy, safety, and the non-titrated maximum tolerated dose. We expect to report results from this cohort by year-end, which will help inform the next stage of development and further demonstrate DA-1726's potential as a best-in-class treatment for obesity." Mr. Kim continued, "With regard to our second asset, vanoglipel (DA-1241), a first-in-class oral GPR119 agonist, the 16-week Phase 2a results demonstrated meaningful reductions in liver fat, inflammation and fibrosis — three key drivers of metabolic dysfunction-associated steatohepatitis (MASH) progression. The data also highlighted vanoglipel's dual anti-inflammatory and anti-fibrotic mechanisms, supporting its potential as a differentiated, hepatoprotective therapy with glucose-regulating benefits. This month, full data from the Phase 2a trial will be presented in a poster at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting 2025. Additionally, we are preparing for an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) during the first half of 2026 to discuss the next stage of clinical development." Third Quarter 2025 and Subsequent Highlights November 2025: Presented new Phase 1 and pre-clinical data on DA-1726 in two poster presentations at ObesityWeek® 2025. The Phase 1 data demonstrated favorable safety and tolerability, a newly characterized pharmacokinetic (PK) profile supporting once-weekly dosing, and meaningful reductions in body weight and waist circumference following four weeks of treatment. Additionally, in a diet-induced obesity (DIO) mouse model, DA-1726 achieved comparable weight loss to pemvidutide with superior lipid-lowering efficacy. August 2025: Administered the fifth weekly dose for the first patient in the 8-week extended 48 mg, MAD cohort of the Phase 1 clinical trial of DA-1726 for the treatment of obesity. The cohort, extended to 8 weeks from 4 weeks, is designed to explore the non-titrated maximum tolerated dose, continue to explore safety over a longer treatment duration, and evaluate early efficacy. August 2025: Announced a research collaboration with Syntekabio, Inc., a leading artificial intelligence (AI)-driven drug discovery company, to identify additional disease targets beyond MASH, and optimize the therapeutic profile of vanoglipel. July 2025: Announced dosing of the first patient in the 48 mg MAD cohort of the Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity, marking a key milestone achievement for this ongoing program. Anticipated Clinical Milestones DA-1726 in Obesity: Data from the 8-week 48 mg MAD cohort to explore the non-titrated maximum tolerated dose is expected by year-end 2025. Vanoglipel (DA-1241) in MASH: The Company is currently working to schedule an end-of-Phase 2 meeting with the FDA during the first half of 2026. Third Quarter Financial and Operating Results Research and Development (R&D) Expenses were approximately $1.9 million for the third quarter ended September 30, 2025, as compared to approximately $4.5 million for the third quarter ended September 30, 2024. The decrease of approximately $2.6 million was primarily attributable to (i) $2.4 million in lower direct R&D expenses related to vanoglipel (DA-1241) product development and (ii) $0.4 million in lower direct R&D expenses related to DA-1726 product development. These decreases were partially offset by (i) $0.1 million in higher direct other R&D costs and (ii) $0.1 million in higher indirect consulting expenses. Included in direct R&D costs were expenses totaling $0.2 million and $0.7 million for the three months ended September 30, 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party). R&D expenses were approximately $6.6 million for the nine months ended September 30, 2025, as compared to approximately $17.5 million for the nine months ended September 30, 2024. The approximately $10.9 million decrease was primarily attributable to (i) $7.6 million in lower direct R&D expenses related to vanoglipel (DA-1241) product development, (ii) $3.3 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.1 million in lower direct other R&D costs. These decreases were partially offset by $0.1 million in higher indirect employee compensation and benefits cost and $0.1 million in higher indirect consulting expenses. Included in direct R&D costs were expenses totaling $2.6 million and $4.3 million for the nine months ended September 30, 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party). General and Administrative (G&A) Expenses were approximately $1.6 million for the third quarter ended September 30, 2025, as compared to approximately $1.7 million for the third quarter ended September 30, 2024. The approximately $0.2 million decrease was primarily attributable to (i) $0.1 million in lower consulting expenditures, (ii) $0.1 million in lower employee compensation and benefits, and (iii) $0.1 million in lower other G&A expenses. These decreases were partially offset by $0.1 million in higher legal and professional fees. G&A expenses were approximately $5.1 million for the nine months ended September 30, 2025, as compared to approximately $5.7 million for the nine months ended September 30, 2024. The approximately $0.6 million decrease was primarily attributable to (i) $0.9 million in lower consulting expenditures and (ii) $0.2 million in lower G&A expenses. These decreases were partially offset by (i) $0.4 million in higher legal and professional fees and (ii) $0.1 million in higher employee compensation and benefits. Total Operating Expenses were approximately $3.5 million for the third quarter ended September 30, 2025, compared to approximately $6.3 million for the third quarter ended September 30, 2024. The approximately $2.8 million decrease was primarily attributable to lower R&D expenses. Total Operating expenses were approximately $11.7 million for the nine months ended September 30, 2025, compared to approximately $23.2 million for the nine months ended September 30, 2024. The approximately $11.6 million decrease was primarily attributable to lower R&D and G&A expenses for the nine months ended September 30, 2025. Total Other Income was approximately $0.1 million for the third quarter ended September 30, 2025, compared to approximately $0.6 million for the third quarter ended September 30, 2024. The approximately $0.5 million decrease was primarily attributable to (i) $0.2 million in lower interest income, net, due to lower cash balances and lower interest rates and (ii) $0.4 million related to the change in fair value of warrant liabilities. The Company recorded a loss of $0.1 million from the change in fair value of warrant liabilities during the three months ended September 30, 2025 compared to a gain of $0.3 million from the change in fair value of warrant liabilities during the three months ended September 30, 2024. Total other income was approximately $0.6 million for the nine months ended September 30, 2025, as compared to approximately $0.8 million for the nine months ended September 30, 2024. The approximately $0.2 million decrease was primarily attributable to $0.3 million in lower interest income, net, due to lower cash balances and lower interest rates, partially offset by a $0.1 million increase in gain from change in fair value of warrant liabilities. The Company recorded a gain of $0.2 million from the change in fair value of warrant liabilities during the nine months ended September 30, 2025 compared to $0.1 million from the change in fair value of warrant liabilities during the nine months ended September 30, 2024. Net Loss for the third quarter ended September 30, 2025, was $3.4 million, or $0.14 per basic and diluted share, based on 24,415,876 weighted average shares of common stock outstanding, compared with a net loss of $5.7 million, or $0.55 per basic and diluted share, based on 10,214,087 weighted average shares of common stock outstanding for the third quarter ended September 30, 2024. Net loss for the nine months ended September 30, 2025, was approximately $11.0 million, or $0.63 per basic and diluted share, based on 17,517,322 weighted average shares of common stock outstanding, compared with a net loss of approximately $22.4 million, or $3.24 per basic and diluted share, based on 6,922,338 weighted average shares of common stock outstanding, for the nine months ended September 30, 2024. Cash was $14.3 million as of September 30, 2025, compared with $16.0 million as of December 31, 2024. The company expects its cash position will be adequate to fund operations into 2026. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing vanoglipel (DA-1241) for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. Vanoglipel is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, vanoglipel demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, vanoglipel demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K and its subsequent Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] - Tables to Follow - View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-third-quarter-2025-financial-results-and-provides-corporate-update-302606789.html

By David Bautz, PhD NASDAQ:MTVA READ THE FULL MTVA RESEARCH REPORT Business Update DA-1726 48 mg Cohort Study Extended to Eight Weeks On August 6, 2025, MetaVia, Inc. (NASDAQ:MTVA) announced that the company has extended the 48 mg multiple ascending dose (MAD) cohort of the Phase 1 clinical trial of DA-1726, the company’s oxyntomodulin (OXM) analog that is a dual agonist of the glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The purpose of the extension is to explore the safety and longer-term early efficacy along with other secondary endpoints. We anticipate topline results in the fourth quarter of 2025. MetaVia previously announced positive results from the 32 mg dose that demonstrated a maximum reduction in body weight of -6.3%, a mean body weight reduction of -4.3% (-3.1% placebo adjusted; P=0.0005), early satiety in 83% of patients, and waist reductions of up to 3.9 inches by Day 33. In addition, DA-1726 showed an overall favorable safety and tolerability profile, as shown in the following chart. All of the adverse events (AEs) in the 32 mg cohort were considered mild to moderate and there were no treatment-related discontinuations. There was no diarrhea reported as well as no significant changes in heart rate in this cohort. The three subjects who experienced vomiting in the 32 mg cohort all reported it after the first dose but with no reoccurrence. Similarly, the two subjects who experienced mild nausea after the first dose reported that it resolved within 12 hours and there were no additional reports of nausea after the 2nd and subsequent doses. Overall, we view the AE profile observed thus far as a clear differentiator for DA-1726. One of the concerns with targeting GLP-1 and glucagon receptors is the potential for increased heart rate. Novo Nordisk discontinued the development of NN1177, a dual glucagon/GLP-1 co-agonist, despite achieving weight loss up to 12.6% at week 12 after multiple Phase 1 trials showed an increase in heart rate (5-22 beats per minute), impaired glucose tolerance, and increased markers of inflammation (fibrinogen and C-reactive protein) (Friedrichsen et al., 2023). Thus, determining cardiac safety is of the utmost importance for DA-1726 given its similar mechanism of action. In the Phase 1 study, the mean heart rate for subjects on DA-1726 showed a slight decrease from baseline in all treatment groups besides the 16 mg group where the baseline was significantly lower than the others. In addition, there were no onsets of QTcF (QT interval corrected for heart rate using the methods of Fridericia) and no risk of cardiovascular events. We’re very encouraged by the results from the MAD Part 2 of the Phase 1 trial of DA-1726 as the drug appears to be effective, well tolerated, and shows no signs of any potential negative cardiovascular effects. We look forward to reviewing the 8-week data from the 48 mg cohort later in 2025. AI-Driven Collaboration with Syntekabio On August 4, 2025, MetaVia announced a research collaboration with Syntekabio, Inc. to identify additional disease targets for DA-1241, the oral G-protein coupled receptor 119 (GPR119) agonist that is being developed as a treatment for metabolic dysfunction-associated steatohepatitis (MASH). Due to the strong safety and tolerability profile exhibited in the Phase 2a trial of DA-1241, the company will work with Syntekabio’s proprietary DeepMatcher® compound-protein interaction (CPI) AI prediction platform in an effort to expand the potential uses of the drug. Specifically, a large-scale virtual screening of more than 1,700 validated protein targets will be conducted to discover new, high-potential indications while ensuring specificity and minimizing the risk of off-target effects. Initial insights from the collaboration could be released by the company before the end of 2025. While the company will be pursuing potential additional indications for DA-1241, MASH will remain the primary development focus. In support of this, MetaVia is working to schedule an ‘End-of-Phase 2’ meeting with the U.S. FDA to determine next steps for the MASH program. Financial Results On August 7, 2025, MetaVia announced financial results for the second quarter of 2025. As expected, the company did not report any revenues in the second quarter of 2025. R&D expenses for the second quarter of 2025 were approximately $2.3 million compared to approximately $8.1 million for the second quarter of 2024. The decrease was primarily due to decreased expenses related to DA-1241 and DA-1726. G&A expenses were approximately $2.0 million for the second quarters of both 2025 and 2024. As of June 30, 2025, MetaVia had approximately $17.6 million in cash and cash equivalents. We estimate the company has sufficient capital to fund operations into the first quarter of 2026. As of August 7, 2025, MetaVia had approximately 24.2 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 32.2 million. Conclusion We are very interested to see the results from the 8-week, 48 mg cohort of the DA-1726 Phase 1 trial, which we anticipate being announced in the fourth quarter of 2025. Thus far, DA-1726 has had a very favorable safety and tolerability profile, with positive signs of early efficacy. If this trend continues in the 8-week data, we believe DA-1726 could become a very competitive asset in the obesity space. As we await the 8-week data there have been no changes to our model and our valuation remains at $21 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.

Dosed the First Patient in the 8-Week 48 mg MAD Cohort of its Phase 1 Clinical Trial to Further Explore Maximum Tolerated Dose of DA-1726 for the Treatment of Obesity; Top-Line Data Expected in the Fourth Quarter of 2025 Signed AI-Driven Collaboration with Syntekabio to Explore Additional Indications for DA-1241 Beyond MASH $17.6 Million in Cash at End of Second Quarter is Expected to Fund the Company Into 2026 CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate strategic update. "During the second quarter and recently, we continued to make significant progress advancing the clinical development of our two next-generation cardiometabolic assets," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "A key milestone was the dosing of the first patient in the 48 mg multiple ascending dose (MAD) Phase 1 trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that targets both the glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. Most recently, we announced the extension of this 48 mg cohort to 8-weeks, in order to evaluate longer-term early efficacy and safety, while exploring the maximum tolerated dose without the need for titration. Previously reported clinical data from the 32 mg dose cohort highlighted DA-1726's best-in-class potential, demonstrating a compelling safety and tolerability profile without the need for dose titration. The 48 mg cohort is expected to build on a clear dose-dependent trend in weight reduction seen across the 8 to 32 mg range, potentially unlocking greater efficacy with extended use. We expect the 32 mg dose will serve as the starting point for future clinical trials." "In prior cohorts, DA-1726 at the 32 mg dose demonstrated weight loss (average 4.3%, max 6.3%, p=0.0005 by Day 26), with 83% of patients reporting early satiety. By Day 33, waist circumference decreased by an average of 1.6 inches (max 3.9 inches), aligning with glucagon-driven adipose effects observed in preclinical models. Fasting glucose was reduced by up to 18 mg/dL without hypoglycemia, highlighting its promise in treating obesity and related metabolic disorders. Cardiovascular safety was also favorable—no QTcF prolongation and reduced heart rate across most cohorts—despite dual agonism. GI side effects were mild, transient, and infrequent, suggesting better tolerability than current GLP-1 therapies. We look forward to reporting data from the 8-week 48 mg cohort in the fourth quarter of this year. Following our successful private placement for aggregate gross proceeds of $10.0 million in May, we remain well-capitalized to reach this milestone, with our runway now extended into 2026." Mr. Kim continued, "In June, we presented new pre-clinical data on DA-1241, a first-in-class oral GPR119 agonist, at the American Diabetes Association's (ADA) 85th Scientific Sessions. The new data further underscores the potential of combining DA-1241 with an FGF21 analogue, such as Efruxifermin. For the first time, this combination therapy showed synergistic benefits in reducing liver fat, inflammation, and fibrosis, three key drivers of MASH progression. Additionally, our 16-week Phase 2a results, presented at the EASL Congress 2025, highlighted DA-1241's dual mechanism of action through anti-inflammatory and anti-fibrotic pathways, which demonstrated DA-1241's hepatoprotective and glucose-regulating effects. Together, these findings reinforce our confidence in DA-1241's potential as part of a combination approach to effectively address the complex pathology of MASH. We are currently working to schedule an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). Based on the strong safety data from the Phase 2a trial, we signed a collaboration agreement with Syntekabio to potentially enhance the value of DA-1241 beyond MASH, by using their DeepMatcher® AI platform to screen over 1,700 validated protein targets. This approach aims to identify new, high-potential indications while ensuring specificity and reducing off-target risks. We believe this well-tolerated oral candidate can address significant unmet needs and look forward to early insights later this year." Second Quarter 2025 and Subsequent Highlights August 2025: Administered the fifth dose for the first patient in the 8-week extended 48 mg, MAD cohort of the Phase 1 clinical trial of DA-1726 for the treatment of obesity. The cohort, extended to 8 weeks from 4 weeks, is designed to explore the maximum tolerated dose further, continue to explore safety over a longer treatment duration, and evaluate early efficacy. August 2025: Announced a research collaboration with Syntekabio, Inc., a leading artificial intelligence (AI)-driven drug discovery company, to identify additional disease targets beyond MASH, and optimize the therapeutic profile of DA-1241. July 2025: Dosed the first patient in the 4-week 48 mg MAD cohort of the Phase 1 clinical trial of DA-1726, for the treatment of obesity, to further explore the maximum tolerated dose. June 2025: After the conclusion of the virtual 2025 Annual Meeting of Stockholders on June 30, 2025, all outstanding pre-funded warrants issued in May 2025 were exercised for 4,605,162 shares of the Company's common stock. June 2025: Presented preclinical data on DA-1241 in a poster presentation at the ADA's 85th Scientific Sessions. The data demonstrated additive hepatoprotective effects in combination with Efruxifermin, a fibroblast growth factor 21 (FGF21) analogue, in a metabolic dysfunction-associated steatohepatitis (MASH) mouse model. May 2025: Closed on a private placement offering with Dong-A ST, a related party, and Dong-A Socio Holdings Co., Ltd., the parent company of Dong-A ST, and received gross proceeds of $10.0 million, before deducting the placement agent's fees and related offering expenses. The offering was priced at-the-market under Nasdaq rules. May 2025: Presented data from the 16-week Phase 2a clinical trial of DA-1241 in patients with presumed MASH in a late-breaking poster presentation at EASL Congress 2025. In this trial, DA-1241 significantly decreased plasma ALT levels, with a mean reduction of 22.8 U/L at 16 weeks, Controlled Attenuation Parameter (CAP) Score improved by 23.0 dB/m, indicating reduced liver fat content, while an improvement in FibroScan-AST (FAST) score and NIS-4, supports beneficial effects on liver health. April 2025: Reported additional positive top-line results from the 4-week MAD Part 2 of its Phase 1 clinical trial of DA-1726 for the treatment of obesity further demonstrating its best-in-class potential. DA-1726 demonstrated a clear dose-responsive trend in body weight reduction across the 8 mg to 32 mg range, indicating potentially greater efficacy at higher doses and longer duration of use. Additionally, body mass index, which shows body weight adjusted for height, showed a difference between the treatment group and the placebo group, which was even more pronounced, further supporting the dose-dependent effect of the drug on weight-related outcomes. Of note, DA-1726 did not show any clinically significant increases in heart rate or QTcF changes up to 32 mg at 4 weeks of administration. April 2025: Reported all outstanding pre-funded warrants issued in June 2024 were exercised for 1,430,000 shares of the Company's common stock. April 2025: Announced positive top-line results from the 4-week MAD Part 2 of its Phase 1 clinical trial of DA-1726 for the treatment of obesity. DA-1726 demonstrated excellent safety and tolerability, with positive clinical activity. The cohort receiving 32 mg of DA-1726 with no titration demonstrated a maximum reduction in body weight from baseline ranging up to -6.3%, and a mean body weight reduction of -4.3% at Day 26 (p=0.0005). Four out of six subjects on the 32 mg dose experienced mild gastrointestinal (GI) adverse events (AEs), most of which were resolved after 24 hours of occurrence. There were no treatment-related discontinuations or serious adverse events (SAEs). Anticipated Clinical Milestones DA-1726 in Obesity: Data from the 8-week 48 mg MAD cohort to explore the maximum tolerated dose is expected in the fourth quarter of 2025. DA-1241 in MASH: The Company is currently working to schedule an end-of-Phase 2 meeting with the FDA. Second Quarter Financial and Operating Results Research and Development (R&D) Expenses were approximately $2.3 million for the second quarter ended June 30, 2025, as compared to approximately $8.1 million for the second quarter ended June 30, 2024. The decrease of approximately $5.8 million was primarily attributable to (i) $2.4 million in lower direct R&D expenses related to DA-1241 product development, (ii) $3.4 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.1 million in lower direct other R&D costs. These decreases were partially offset by an aggregate $0.1 million increase in indirect R&D expenses related to employee compensation and benefits and consulting. Included in direct R&D costs were expenses totaling $1.3 million and $3.4 million for the three months ended June 30, 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party). R&D expenses were approximately $4.6 million for the six months ended June 30, 2025, as compared to approximately $13.0 million for the six months ended June 30, 2024. The approximately $8.3 million decrease was primarily attributable to (i) $5.3 million in lower direct R&D expenses related to DA-1241 product development, (ii) $2.9 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.3 million in lower direct other R&D costs. These decreases were partially offset by $0.2 million in higher indirect R&D expenses related to employee compensation and benefits. Included in direct R&D costs were expenses totaling $2.4 million and $3.6 million for the six months ended June 30, 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party). General and Administrative Expenses were approximately $2.0 million for the second quarter ended June 30, 2025 and 2024. G&A expenses were approximately $3.5 million for the six months ended June 30, 2025, as compared to approximately $4.0 million for the six months ended June 30, 2024. The approximately $0.4 million decrease was primarily attributable to (i) $0.7 million in lower consulting expenditures and (ii) $0.2 million in lower other G&A expenses. These decreases were partially offset by (i) $0.3 million in higher legal and professional fees and (ii) $0.2 million in higher employee compensation and benefits. Total Operating Expenses were approximately $4.3 million for the second quarter ended June 30, 2025, compared to approximately $10.1 million for the second quarter ended June 30, 2024. The approximately $5.8 million decrease was primarily attributable to lower R&D expenses. Total Operating expenses were approximately $8.2 million for the six months ended June 30, 2025, compared to approximately $17.0 million for the six months ended June 30, 2024. The approximately $8.8 million decrease was primarily attributable to lower R&D and general and administrative expenses for the six months ended June 30, 2025. Total Other Income was approximately $0.3 million for the second quarter ended June 30, 2025, compared to approximately $31 thousand for the second quarter ended June 30, 2024. The approximately $0.3 million increase was mainly attributable to the $0.3 million increase in the change in fair value of warrant liabilities. The Company recorded a gain of $0.2 million from the change in fair value of warrant liabilities during the three months ended June 30, 2025 compared to a loss of $0.1 million from the change in fair value of warrant liabilities during the three months ended June 30, 2024. Total other income was approximately $0.5 million for the six months ended June 30, 2025, as compared to approximately $0.2 million for the six months ended June 30, 2024. The approximately $0.3 million increase was primarily attributable to the $0.5 million increase in the change in fair value of warrant liabilities, partially offset by $0.1 million in lower interest income. The Company recorded a gain of $0.2 million from the change in fair value of warrant liabilities during the six months ended June 30, 2025 compared to a loss of $0.2 million from the change in fair value of warrant liabilities during the six months ended June 30, 2024. The decrease in interest was due to a lower average invested amount during the six months ended June 30, 2025 and lower interest rates. Net Loss for the second quarter ended June 30, 2025, was $4.0 million, or $0.26 per basic and diluted share, based on 15,287,278 weighted average shares of common stock outstanding, compared with a net loss of $10.1 million, or $1.85 per basic and diluted share, based on 5,428,906 weighted average shares of common stock outstanding for the second quarter ended June 30, 2025. Net loss for the six months ended June 30, 2025, was approximately $7.7 million, or $0.60 per basic and diluted share, based on 12,789,616 weighted average shares of common stock, basic and diluted, compared with a net loss of approximately $16.8 million, or $3.19 per basic and diluted share, based on 5,259,939 weighted average shares of common stock, basic and diluted, for the six months ended June 30, 2024. Cash was $17.6 million as of June 30, 2025, compared with $16.0 million as of December 31, 2024. The company expects its cash position will be adequate to fund operations into 2026. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K and its subsequent Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] - Tables to Follow - View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-second-quarter-2025-financial-results-and-provides-corporate-update-302523790.html SOURCE MetaVia Inc.

By David Bautz, PhD NASDAQ:MTVA READ THE FULL MTVA RESEARCH REPORT Business Update Additional Positive Data from Phase 1 MAD Study of DA-1726 in Obesity On April 22, 2025, MetaVia Inc. (NASDAQ:MTVA) announced additional positive topline results from the multiple ascending dose (MAD) Part 2 of the Phase 1 clinical trial of DA-1726 in obesity. The company had previously announced positive data from this trial, which we discussed in our last report. The additional data showed a clear dose-response in body weight reduction across the 8 mg to 32 mg range and indicating the potential for greater efficacy at higher doses and longer treatment durations. The following image shows the change in body mass index (BMI), showing a clear dose-dependent effect from the 8 mg to the 32 mg cohort. One of the concerns with targeting GLP-1 and glucagon receptors is the potential for increased heart rate. Novo Nordisk discontinued the development of NN1177, a dual glucagon/GLP-1 co-agonist, despite achieving weight loss up to 12.6% at week 12 after multiple Phase 1 trials showed an increase in heart rate (5-22 beats per minute), impaired glucose tolerance, and increased markers of inflammation (fibrinogen and C-reactive protein) (Friedrichsen et al., 2023). Thus, determining cardiac safety is of the utmost importance for DA-1726 given its similar mechanism of action. In the Phase 1 study, the mean heart rate for subjects on DA-1726 showed a slight decrease from baseline in all treatment groups besides the 16 mg group where the baseline was significantly lower than the others. In addition, there were no onsets of QTcF (QT interval corrected for heart rate using the methods of Fridericia) and no risk of cardiovascular events. We’re very encouraged by the results from the MAD Part 2 of the Phase 1 trial of DA-1726 as the drug appears to be effective, well tolerated, and shows no signs of any potential negative cardiovascular effects. The company is planning to add additional cohorts to the study to examine higher doses of DA-1726 as the 32 mg dose appears to be very well tolerated. In addition, MetaVia will be initiating Part 3 of the Phase 1 trial in the second half of 2025. The trial will utilize the 32 mg dose and focus on Wegovy® early drop-out patients with the goal being to explore the potential of DA-1726 to have a superior tolerability/safety and weight loss profile. The interim data readout for this trial should occur in the first half of 2026. Data on DA-1241 Presented at EASL Congress 2025 On May 7, 2025, MetaVia announced that data from the Phase 2a clinical trial of DA-1241 was presented in a late-breaking poster session at the European Association for the Study of the Liver (EASL) Congress 2025. A copy of the poster can be found here. The Phase 2a trial enrolled a total of 109 subjects with presumed metabolic dysfunction-associated steatohepatitis (MASH) and qualifying baseline alanine aminotransferase (ALT). Subjects were randomized to receive DA-1241 50 mg, DA-1241 100 mg alone, DA-1241 100 mg with dipeptidyl peptidase 4 inhibitor (DPP4i), or placebo in a 1:2:2:2 ratio once daily for 16 weeks. The primary efficacy endpoint was the change from baseline in ALT after 16 weeks. We previously reported on the topline results, which can be seen here. Additional data from the study shared during the poster session included a subgroup analysis of subjects with baseline ALT levels between 40 and 200 U/L, in which DA-1241 treatment led to dose-dependent reductions in ALT, with the 100 mg dose producing a significant 22.8 U/L decrease after 16 weeks (P<0.05 vs. placebo). The effects were seen regardless of diabetes status and were also accompanied by improvements in non-invasive tests used to monitor MASH such as FAST, CAP, MRI-PDFF, and NIS-4 score. Liver fat, as measured by CAP, was reduced by 23.0 dB/m with DA-1241 100 mg compared to just 1.4 dB/m with placebo. We anticipate the company conducting an ‘End-of-Phase 2’ meeting with the FDA to discuss the regulatory path forward for DA-1241 in the first half of 2025. Financial Results On May 14, 2025, MetaVia announced financial results for the first quarter of 2025. As expected, the company did not report any revenues in the first quarter of 2025. R&D expenses for the first quarter of 2025 were approximately $2.3 million compared to approximately $4.9 million for the first quarter of 2024. The decrease was primarily due to decreased expenses related to DA-1241 partially offset by higher expenses related to DA-1726. G&A expenses were approximately $1.6 million for the first quarter of 2025 compared to $2.0 million for the first quarter of 2024. The decrease was primarily due to lower consulting and other G&A expenses. As of March 31, 2025, MetaVia had approximately $11.2 million in cash and cash equivalents. Subsequent to the end of the quarter, the company raised gross proceeds of $10.0 million from the sale of 9,479,345 shares of common stock at $0.71 per share and 4,605,162 pre-funded warrants to purchase shares of common stock at a price of $0.709 per pre-funded warrant. We estimate the company has sufficient capital to fund operations into 2026. As of May 14, 2025, MetaVia had approximately 19.6 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 5.1 million. Conclusion The market’s reaction to the MAD data does not seem to align with the quality of the data that the company presented. We aren’t sure why this is, but regardless we feel that DA-1726 has the potential to be a very competitive asset in the obesity space. We look forward to the data from the higher dose cohorts and for the company to initiate Part 3 of the trial with Wegovy early dropouts, which has the potential to clearly differentiate the asset. We had previously modeled for better terms for the company’s next raise, thus after incorporating the most recent financing into our model our valuation is now at $21 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. 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Announced Positive Top-Line Phase 1 MAD Trial Results for DA-1726 in Obesity, Demonstrating Compelling Weight Loss and Best-in-Class Potential for Glucose Control, Waist Reduction and Tolerability Additional Cohorts Planned to Determine Maximum Tolerated Dose of DA-1726 Successfully Completed a Private Placement Resulting in $10 Million in Gross Proceeds $11.2 Million in Cash at End of First Quarter, With the Additional $10.0 Million From the Private Placement, is Expected to Fund the Company Into 2026 CAMBRIDGE, Mass., May 14, 2025 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the first quarter ended March 31, 2025, and provided a corporate strategic update. "In the first quarter and beyond, we achieved significant progress advancing the clinical development of our two next-generation cardiometabolic assets, highlighted by the positive results from Part 2 of the multiple ascending dose (MAD) Phase 1 trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) for the treatment of obesity," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "We are now well capitalized into 2026 after a successful private placement of $10 million in aggregate gross proceeds. The data reinforce DA-1726's strong potential as a best-in-class therapy, demonstrating, without titration, a compelling safety and tolerability profile alongside dose-dependent weight loss, reaching a maximum reduction of 6.3% and a mean reduction of 4.3% at the 32 mg dose at Day 26 (p=0.0005). Additionally, at this dose, 83% of patients reported early satiety, and waist circumference decreased by an average of 1.6 inches and a maximum of 3.9 inches by Day 33, consistent with DA-1726's glucagon-driven effects on adipose tissue observed in preclinical models. The drug also achieved fasted glucose reductions of up to -18 mg/dL without hypoglycemic events, further underscoring its potential in obesity and related metabolic diseases. Cardiovascular safety remained favorable, with no QTcF prolongation and a decrease in mean heart rate across most cohorts, despite dual receptor agonism. Gastrointestinal side effects were mild, transient, and infrequent, suggesting a potentially superior tolerability profile compared to existing GLP-1 therapies." "Building on these encouraging findings, we are initiating higher-dose cohorts to identify the maximum tolerated dose and further unlock DA-1726's full therapeutic potential. Our aim is to deliver a safe, effective and sustainable obesity treatment for patients across a broad range of comorbidities, consistent with guidance from the U.S. Food and Drug Administration (FDA)." Mr. Kim continued, "This month, we presented compelling 16-week results, in a late-breaking poster, from our Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH) at the European Association for the Study of the Liver (EASL) Congress 2025. DA-1241 is the first oral GPR119 agonist to demonstrate both liver-protective and glucose-regulating effects. The data showed that DA-1241 significantly reduced markers of liver injury, inflammation, and fibrosis, improved non-invasive liver assessments, CAP and FAST scores, and enhanced glycemic control in patients with prediabetes or type 2 diabetes. It was well tolerated with a favorable safety profile. These findings suggest DA-1241's benefits extend beyond glycemic control, driven by its anti-inflammatory and anti-fibrotic mechanisms. We believe its novel mechanism of action supports further development as monotherapy or in combination for MASH and metabolic diseases, and we are exploring additional combination therapies. We look forward to discussing these findings with the FDA in the first half of 2025." Fourth Quarter 2024 and Subsequent Highlights May 2025: Closed a private placement, which resulted in aggregate gross proceeds of $10 million priced at-the-market under Nasdaq rules. May 2025: Presented data from the 16-week Phase 2a clinical trial of DA-1241 in patients with presumed MASH in a late-breaking poster presentation at EASL Congress 2025. In this trial, DA-1241 significantly decreased plasma ALT levels, with a mean reduction of 22.8 U/L at 16 weeks, Controlled Attenuation Parameter (CAP) Score improved by 23.0 dB/m, indicating reduced liver fat content, while an improvement in FibroScan-AST (FAST) score and NIS-4, supports beneficial effects on liver health. April 2025: Reported additional positive top-line results from the 4-week MAD Part 2 of its Phase 1 clinical trial of DA-1726 for the treatment of obesity further demonstrating its best-in-class potential. DA-1726 demonstrated a clear dose-responsive trend in body weight reduction across the 8 mg to 32 mg range, indicating potentially greater efficacy at higher doses and longer duration of use. Additionally, body mass index, which shows body weight adjusted for height, showed a difference between the treatment group and the placebo group, which was even more pronounced, further supporting the dose-dependent effect of the drug on weight-related outcomes. Of note, DA-1726 did not show any clinically significant increases in heart rate or QTcF changes up to 32 mg at 4 weeks of administration. April 2025: Reported previously issued and outstanding pre-funded warrants were exercised for 1,430,000 shares of the Company's common stock -- leaving no pre-funded warrants outstanding. April 2025: Announced positive top-line results from the 4-week MAD Part 2 of its Phase 1 clinical trial of DA-1726 for the treatment of obesity. DA-1726 demonstrated excellent safety and tolerability, with positive clinical activity. The cohort receiving 32 mg of DA-1726 with no titration demonstrated a maximum reduction in body weight from baseline ranging up to -6.3%, and a mean body weight reduction of -4.3% at Day 26 (p=0.0005). Four out of six subjects on the 32 mg dose experienced mild gastrointestinal (GI) adverse events (AEs), most of which were resolved after 24 hours of occurrence. There were no treatment-related discontinuations or serious adverse events (SAEs). January 2025: Held an Advisory Committee meeting at the 9th Annual MASH-TAG 2025 Conference, to discuss the positive top-line 16-week results from the two-part Phase 2a clinical trial of DA-1241. Anticipated Clinical Milestones DA-1726 in Obesity: Additional SAD/MAD cohorts to explore the maximum tolerated dose expected to begin in the third quarter of 2025, with data expected in the fourth quarter of 2025. DA-1241 in MASH: The Company expects to have an end-of-Phase 2 meeting with the FDA in the first half of 2025. First Quarter Financial and Operating Results Research and Development (R&D) Expenses were approximately $2.3 million for the first quarter ended March 31, 2025, as compared to approximately $4.9 million for the first quarter ended March 31, 2024. The decrease of approximately $2.6 million was primarily attributable to (i) $2.9 million in lower direct R&D expenses related to DA-1241 product development and (ii) $0.2 million in lower direct other R&D costs. These decreases were partially offset by (i) $0.5 million in higher direct R&D expenses related to DA-1726 product development and (ii) $0.1 million in higher indirect R&D expenses related to employee compensation and benefits. Included in direct R&D costs were expenses totaling $1.1 million and $0.2 million for the three months ended March 31, 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A (related party). General and Administrative Expenses were approximately $1.6 million for the first quarter ended March 31, 2025, compared to approximately $2.0 million for the first quarter ended March 31, 2024. The decrease of approximately $0.4 million was primarily due to (i) $0.4 million in lower consulting expenditures and (ii) $0.2 million in lower other G&A expenses. These decreases were partially offset by $0.2 million in higher employee compensation and benefits. Total Operating Expenses were approximately $3.9 million for the first quarter ended March 31, 2025, compared to approximately $6.9 million for the first quarter ended March 31, 2024. The approximately $3.0 million decrease was attributable to lower R&D and general and administrative expenses. Total Other Income for the three months ended March 31, 2025 and 2024 remained relatively consistent at $0.2 million. The net increase in the gain from the change in fair value of warrant liabilities during the three months ended March 31, 2025 was partially offset by a decrease in interest income earned on the Company's cash balance during the three months ended March 31, 2025. Net Loss for the first quarter ended March 31, 2025, was $3.7 million, or $0.36 per basic and diluted share, based on 10,264,202 weighted average shares of common stock outstanding, compared with a net loss of $6.7 million, or $1.32 per basic and diluted share, based on 5,089,408 weighted average shares of common stock outstanding for the first quarter ended March 31, 2025. Cash was $11.2 million as of March 31, 2025, compared with $16.0 million as of December 31, 2024. The company expects its cash position, together with the proceeds from the private placement transaction, will be adequate to fund operations into 2026. About MetaVia MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects. For more information, please visit www.metaviatx.com. Forward Looking Statements Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "potential", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K and its subsequent Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date when made. MetaVia does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contacts: MetaVia Marshall H. Woodworth Chief Financial Officer +1-857-299-1033 [email protected] Rx Communications Group Michael Miller +1-917-633-6086 [email protected] - Tables to Follow - View original content to download multimedia:https://www.prnewswire.com/news-releases/metavia-reports-first-quarter-2025-financial-results-and-provides-corporate-update-302455666.html SOURCE MetaVia Inc.